CYB003
CYB003:
Deuterated Psilocin Program with FDA Breakthrough Therapy Designation
CYB003 is a proprietary deuterated psilocin molecule. Psilocin is part of a family of molecules called indoleamines that are structurally similar to neurotransmitters such as serotonin, and acts as a 5-HT2A receptor agonist.
CYB003 is a new chemical entity (NCE) and has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of Major Depressive Disorder (MDD).
Development Status: Initiated APPROACH, the first pivotal study in Cybin’s Phase 3 PARADIGM program in participants with moderate to severe MDD
Upcoming Milestones: Initiate second pivotal study, EMBRACE around mid-2025
PARADIGM:
CYB003 Phase 3 Pivotal Program in MDD
The pivotal program will consist of 2 studies plus an extension study:
• APPROACH: Two-arm study of two doses of CYB003 vs. placebo
• EMBRACE: Three-arm study with a high dose, mid-dose, and placebo arm
• EXTEND: Long-term extension study that allows for open-label dosing or re-dosing for participants who did not respond in the first two studies or relapsed during the extension study
Expanded Access Policy
We do not offer expanded access at this time.
Discover Cybin’s complete Research and Development Progress.
CYB003 received the first known Breakthrough Therapy Designation for an adjunctive tryptamine-based therapy for MDD
This designation acknowledges the significant unmet medical need for more effective treatment of MDD. It also provides validation that Phase 2 data for CYB003 shows preliminary evidence for significant clinical improvements over existing therapies.
Breakthrough Therapy Designation expedites the development pathway for CYB003 with the following benefits:
Breakthrough Therapy Designation benefits:
- All Fast Track Designation features, including Rolling Review for NDA
- More intensive FDA guidance and discussion, including planned clinical trials and plans for expediting manufacturing development strategy
- CYB003 is eligible for Priority Review and Accelerated Approval
CYB003 is in development as an acute, adjunctive therapy, with the potential to offer the following benefits:
- Allows for immediate treatment without waiting to withdraw from background medications
- Prevents withdrawal symptoms, which could be severe for some patients after years of antidepressant use
- Eliminates logistical hurdles associated with titrating off existing medications
- Background medications could provide some benefit even if inadequate alone
Clinical Validation for CYB003 in MDD:
Robust and Sustained Remission Rates up to 12 Months
12 month data highlights, after 2 doses of CYB003 (16 mg):
Mean ~23-point reduction in MADRS scores from baseline
Average baseline MADRS score was ~32
100% of patients were responders
71% of patients were in remission
All reported AEs mild to moderate; no AEs of suicidality
No AEs/SAEs reported in the 12 month follow up
Large Improvement in Depression Symptoms After a Single Dose of CYB003
Response and Remission at 12 Months: 12 mg & 16 mg
